A Phase 2/3 interventional study of Fecal microbiota transplantation and Infusion of Saline in Ulcerative Colitis and Fecal Microbiota Transplantation, sponsored by Guangzhou First People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Guangzhou First People's Hospital · Phase 2/3, Interventional, and Treatment
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Guangzhou First People's Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fecal microbiota transplantation
Procedure: Fecal microbiota transplantation · Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Infusion of Saline
Procedure: Infusion of Saline · Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
Infusion of Saline
Mesalazine and/or Prednisone
Also known as: Mesalazine, Prednisone
Clinical remission in patient as assessed using Mayo score
Total Mayo score less than 2 and no signal item more than 1
Time frame: 12 weeks
Clinical improvement in patient as assessed using Mayo score
Total Mayo score decreased more than 3
Time frame: 12 weeks
Intestinal microbiota changing
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
Time frame: 12 weeks
Plan to share: No
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Guangzhou First People's Hospital